PumpKIN PreClinical

婴儿大小的Jarvik 2000心脏是美国国立卫生研究院儿科VAD项目开发的最小的永久性植入式血泵，据我们所知，是世界上最小的。直径仅10.5mm，长5.2 cm，体积4cc，足以植入3.5 Kg的心室尖部。新生儿，但它的流量超过3L/分钟-足够的输出儿童高达25公斤。动物植入表明，泵仍然没有血栓，并且在低功率下运行而不会引起溶血。该泵是一个完整的设计，包含了长期植入的所有要求，包括电机定子和转子磁铁的焊接密封，电源线的微型密封馈线，超长寿命的陶瓷锥形轴承设计，以及从外部控制器到植入血泵的起搏器型高弯曲寿命电源线。一个先进的基于微处理器的控制系统刚刚完成，尽管只有基本功能的软件（速度设置，测量速度，电池剩余量，电源，通过膜开关显示功能管理）目前可用。这允许基本的操作，但还不能实现一些计划在将来实现的更高级的功能。

The infant size Jarvik 2000 heart is the smallest permanently implantable blood pump developed as part of the NIH Pediatric VAD Program, and to our knowledge, the smallest in the world. At only 10.5mm diameter, 5.2 cm long and 4cc in volume it is small enough to implant in the ventricular apex of 3.5 Kg. newborns yet it has flow capacity over 3L/min - sufficient output for children up to 25 Kg. Animal implants have shown that the pump remains free of thrombus and operates at low power without causing hemolysis. The pump represents a completed design, incorporating all of the requirements for a long term implant, including welded hermetic sealing of the motor stator and rotor magnet, miniature hermetic feed-throughs for the power cables, a very long life ceramic conical bearing design, and pacemaker type high flex life power cables from the external controller to the implanted blood pump. An advanced microprocessor based control system has just been completed, although only the software for the basic functions (speed setting, measured speed, battery remaining, power, display function management via membrane switches) is presently available. This permits basic operation but does not yet implement some of the more advanced functions planned for the future. Jarvik Heart, Inc. is a small company of only 36 employees, but has successfully conducted clinical trials with the adult model Jarvik 2000, has received CE mark approval in Europe, has completed a 63 patient Pilot IDE study, and enrolled 100 of 150 patients in the IDE pivotal bridge to transplant study. The company thus has sufficient experience to sponsor an IDE clinical trial of the infant Jarvik 2000 and to obtain HUD designation and HDE approval. Over the course of the present five year contract we have collaborated successfully with Dr. Griffith's animal laboratory at the University of Maryland, and they will be a major subcontractor if our proposal is funded. Dr. Bartley Griffith, the Co-PI together with Dr. Jarvik, has extensive cardiac surgical experience with numerous mechanical circulatory support devices, and is a pediatric cardiac surgeon as well as an adult surgeon. We have established relationships with major pediatric cardiac surgical centers that have expressed interest in joining an multi-center Clinical Trial to evaluate the pediatric Jarvik2000. These include Dr. William Gaynor (University of Pennsylvania), Dr. Pedro del Nido (Boston Children's Hospital), Dr. Richard Jonas (Washington National Pediatric Center), Dr. Ed Bovie (University of Michigan) and Dr. Marcelo Cardarelli, Dr. Duke Cameron, and Dr. Luca Vricella (University of Maryland & Johns Hopkins). The PIs from each site will comprise an advisory group for the development of our IDE application, and will advise us concerning other clinical matters including surgical technique and patient management.